|Location||Tokai, South Africa|
|Date Posted||Jul 28, 2021|
Strategy and Development
•Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance
•Contribute to new business initiatives and projects
•Maintain and manage the impact of potential product and business risk on Quality Management Systems (QMS)
•Responsible for achieving budget and forecast
Operational management of the QA Department:
•Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.
•Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.
•Liaising with suppliers and distributors with regards to quality issues and complaints
•Reviews and approves finished product specifications.
•Identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.
•Provides oversight and works directly in daily operations and systems within the Quality Assurance program to assure completions of activities on time and in compliance to regulatory guidelines.
•Monitors non-conformances or anomalies to the guidelines and GMP principles and provides timely input to ensure proper completion.
•Manage the adherence to an annual audit plan
•Assesses and reviews the impact of excursions and deviations throughout the manufacturing and packing process.
•Maintains internal and external relationships.
•Assist with training in line with departmental training program when required.
•Implement and manage new and ongoing stability programs
•Management of departmental budgets in line with organizations financial objective
Good Manufacturing practice (GMP, GLP, GWP)
•Maintaining and coordinating all GMP principles
•Conduct risk assessments on a regular basis
•Monitor and approve temperature excursions during product transportation
•Provide Regulatory support relating to compliance and all GMP activities that might impact the dossier or SAHPRA/PIC/s.
Documentation & Systems Management
•Managing the accuracy and completion of all databased entries, registers and forms
•Manages the implementation of new products in line with QA requirements
•Manage annual product reviews, risk management reports and adherence to master documents and SOP’s
•Record and interpret statistical information and trends
•Manage the implementation of technical agreements
•Compiling and presenting management review reports to the EXCO
•Drive operational efficiency by ensuring fit for purpose QMS
•Ensure ongoing compliance with the Quality Management System
•Develop, implement, and monitor overall process mapping for quality improvement purposes and electronic database management
•Setting up goals and objectives in alignment with Scientific Affairs departmental strategies
•Conducting Performance management and appraisals
•Manage conflicts when necessary
•Mentoring and coaching and developing of direct reports
•B. Pharm registered with the SA Pharmacy Council
•minimum 10 years’ work experience in a quality assurance position within a pharmaceutical environment
•5 years Management experience strongly preferred
The company reserves the right to adjust or modify the scope and / or level of the job based on applicant supply, operational requirements and/or prevailing market conditions